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Recruiting NCT05888571

Pre-pectoral Breast Reconstruction With or Without Mesh

No phase Interventional Prepectoral Breast Reconstruction TiLOOP Mesh

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: prepectoral breast reconstruction, Tiloop Mesh implantation.
Who it may be relevant to
Registry conditions: Prepectoral Breast Reconstruction, TiLOOP Mesh. Basic parameters: 18 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized Controlled Trial of Prepectoral Breast Reconstruction With and Without Mesh

Overview

To explore the efficacy and safety that occur after immediate prepectoral breast reconstruction when TiLOOP Mesh is used compared to that when TiLOOP Mesh is not used.

Detailed description

The clinical study aims to explore the efficacy and safety that occur after immediate prepectoral breast reconstruction when TiLOOP Mesh is used compared to that not using TiLOOP Mesh.

Interventions

  • Procedure prepectoral breast reconstruction
    Patients receive immediate prepectoral breast reconstruction
  • Procedure Tiloop Mesh implantation
    Patients receive immediate prepectoral breast reconstruction with Tiloop Mesh

Primary outcome measures

  • Major Complication Rates [Time frame: up to 12 months after surgery]
  • Patient Breast-Q questionnaire [Time frame: up to 12 months after surgery]
Secondary outcome measures (4)
  • Minor Complication Rates [Time frame: up to 12 months after surgery]
  • Rates of capsule contracture [Time frame: up to 24 months after surgery]
  • The rate of surgical revision of reconstructed breasts [Time frame: up to 12 months after surgery]
  • The rate of implant or tissue expander removal [Time frame: up to 12 months after surgery]

Eligibility criteria

Inclusion criteria

  • Adult women aged 18-65 years who plan to undergo unilateral or bilateral immediate prepectoral prothesis breast reconstruction;
  • SSM or NSM or Skin-Reducing Mastectomy for breast cancer patients or prophylactic mastectomy;
  • Tissue expander size =<800cc, implant size =<600cc;
  • The blood perfusion of breast skin flap was well;
  • Do not smoking in the last 4 weeks or more
  • Patients with normal expectations and mental health for breast reconstruction;
  • Signed consent to participate

Exclusion criteria

  • Poor perfusion of breast mastectomy flap;
  • II stage breast reconstruction patients;
  • History of chest radiotherapy;
  • BMI greater than 35;
  • Patients who have not quit smoking within the last 4 weeks;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Tianjin Medical University Cancer Institute and Hospital — Tianjin

Identifiers

NCT: NCT05888571 · E20230013

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗